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FDA 510(k)

Zimmer Biomet Universal Navigation System

K-Number: K192133 · 2019-10-29

ApplicantZimmer Biomet Spine, Inc.
Decision Date2019-10-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Universal Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192133. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Biomet Universal Navigation System?

Zimmer Biomet Universal Navigation System is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K192133.

When did Zimmer Biomet Universal Navigation System receive FDA 510(k) clearance?

Zimmer Biomet Universal Navigation System received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192133.

Who is the listed applicant for Zimmer Biomet Universal Navigation System?

The FDA 510(k) record lists Zimmer Biomet Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zimmer Biomet Universal Navigation System?

The FDA product code for Zimmer Biomet Universal Navigation System is OLO.

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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